System and methods for clinical effects mapping for directional stimulation leads

ABSTRACT

A method includes displaying, on a display coupled to a computer processor, a two-dimensional representation of an arrangement of electrodes of a lead having one or more segmented electrodes; displaying, by the computer processor and on the display, a three-dimensional clinical effects map with two of the dimensions of the clinical effects map corresponding to the two-dimensional representation of the arrangement of the electrode and a third dimension corresponding to a stimulation parameter; and displaying, by the computer processor and on the display, at least one marking on the clinical effects map. Each marking represents a stimulation instance and is displayed at a position corresponding to the electrode used for stimulation in the stimulation instance and a value of the stimulation parameter used for stimulation in the stimulation instance. Each marking has a graphical characteristic representing a therapeutic effect or a side-effect resulting from the stimulation instance.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application Ser. No. 62/239,654, filed Oct. 9, 2015,which is incorporated herein by reference.

FIELD

The invention is directed to the area of electrical stimulation systemsand leads and methods of making and using the systems and leads. Thepresent invention is also directed to systems and methods for mappingclinical effects for directional electrical stimulation leads, as wellas methods of making and using systems.

BACKGROUND

Electrical stimulation can be useful for treating a variety ofconditions. Deep brain stimulation can be useful for treating, forexample, Parkinson's disease, dystonia, essential tremor, chronic pain,Huntington's disease, levodopa-induced dyskinesias and rigidity,bradykinesia, epilepsy and seizures, eating disorders, and mooddisorders. Typically, a lead with a stimulating electrode at or near atip of the lead provides the stimulation to target neurons in the brain.Magnetic resonance imaging (“MRI”) or computerized tomography (“CT”)scans can provide a starting point for determining where the stimulatingelectrode should be positioned to provide the desired stimulus to thetarget neurons.

After the lead is implanted into a patient's brain, electrical stimuluscurrent can be delivered through selected electrodes on the lead tostimulate target neurons in the brain. Typically, the electrodes areformed into rings disposed on a distal portion of the lead. The stimuluscurrent projects from the ring electrodes equally in every direction.Because of the ring shape of these electrodes, the stimulus currentcannot be directed to one or more specific positions around the ringelectrode (e.g., on one or more sides, or points, around the lead).Consequently, undirected stimulation may result in unwanted stimulationof neighboring neural tissue, potentially resulting in undesired sideeffects.

BRIEF SUMMARY

One embodiment is a computer-implemented method including displaying, bya computer processor and on a display coupled to the computer processor,a two-dimensional representation of an arrangement of electrodes of alead having one or more segmented electrodes; displaying, by thecomputer processor and on the display, a three-dimensional clinicaleffects map with two of the dimensions of the clinical effects mapcorresponding to the two-dimensional representation of the arrangementof the electrode and a third dimension corresponding to a stimulationparameter; and displaying, by the computer processor and on the display,at least one marking on the clinical effects map. Each markingrepresents a stimulation instance and is displayed at a positioncorresponding to the electrode used for stimulation in the stimulationinstance and a value of the stimulation parameter used for stimulationin the stimulation instance. Each marking has a graphical characteristicrepresenting a therapeutic effect or a side-effect resulting from thestimulation instance.

In at least some embodiments, the method further includes selecting aone of the at least one marking; and delivering, by the processor,electrical stimulation parameters corresponding to the one of the atleast one marking to an electrical stimulation system for delivery ofelectrical stimulation to a patient using the stimulation parameters. Inat least some embodiments, delivering electrical stimulation parametersincludes delivering, to the electrical stimulation system, anidentification of the electrode associated with the one of the at leastone marking and the value of the stimulation parameter associated withthe one of the at least one marking.

In at least some embodiments, the stimulation parameter to which thethird dimension corresponds is stimulation amplitude. In at least someembodiments, the graphical characteristic is selected from color orcross-hatching. In at least some embodiments, displaying at least onemarking includes displaying the at least one marking with a furthergraphical characteristic representing a score or rating of thetherapeutic effect or the side-effect resulting from the stimulationinstance. In at least some embodiments, the further graphicalcharacteristic is selected from color, shade, intensity, saturation,cross-hatching, or texture.

In at least some embodiments, displaying at least one marking includesdisplaying at least one of the at least one marking with a firstgraphical characteristic representing a first therapeutic effectresulting from the stimulation instance and a second graphicalcharacteristic representing a first side-effect resulting from thestimulation instance. In at least some embodiments, the first graphicalcharacteristic is associated with a surface of the marking and thesecond graphical characteristic is associated with a perimeter ring ofthe marking. In at least some embodiments, displaying at least onemarking includes displaying a plurality of markings associated with oneof the electrodes of the lead in a column.

In at least some embodiments, the method further includes selecting aone of the electrodes in the two-dimensional representation andhighlighting all of the at least one markings associated with theselected electrode. In at least some embodiments, the method furtherincludes displaying, by the computer processor and on the display, athree-dimensional representation of the arrangement of the electrodes ofthe lead separate from, and simultaneously with, the clinical effectsmap and two-dimensional representation. In at least some embodiments,the method further includes selecting a one of the electrodes in thethree-dimensional representation and highlighting all of the at leastone markings associated with the selected electrode and highlighting theselected electrode in the two-dimensional representation. In at leastsome embodiments, the method further includes selecting a one of theelectrodes in the two-dimensional representation and highlighting all ofthe at least one markings associated with the selected electrode andhighlighting the selected electrode in the three-dimensionalrepresentation. In at least some embodiments, the method furtherincludes selecting a one of the at least one marking and highlightingthe one of the at least one marking and the electrode, in thetwo-dimensional representation, associated with the selected one of theat least one marking.

Another embodiment is a system for mapping clinical effects ofelectrical stimulation, the system including a display and a computerprocessor coupled to the display and configured and arranged to performthe following actions: display, on the display, a two-dimensionalrepresentation of an arrangement of electrodes of a lead having one ormore segmented electrodes; display, on the display, a three-dimensionalclinical effects map with two of the dimensions of the clinical effectsmap corresponding to the two-dimensional representation of thearrangement of the electrode and a third dimension corresponding to astimulation parameter; and display, on the display, at least one markingon the clinical effects map. Each marking represents a stimulationinstance and is displayed at a position corresponding to the electrodeused for stimulation in the stimulation instance and a value of thestimulation parameter used for stimulation in the stimulation instance.Each marking has a graphical characteristic representing a therapeuticeffect or a side-effect resulting from the stimulation instance.

In at least some embodiments, the actions further include receive aselection of a one of the at least one marking; and transmit electricalstimulation parameters corresponding to the one of the at least onemarking to an electrical stimulation system for delivery of electricalstimulation to a patient using the stimulation parameters. In at leastsome embodiments, the actions further include display, on the display, athree-dimensional representation of the arrangement of the electrodes ofthe lead separate from, and simultaneously with, the clinical effectsmap and two-dimensional representation.

Yet another embodiment is a non-transitory computer-readable mediumhaving processor-executable instructions for mapping clinical effects ofelectrical stimulation, the processor-executable instructions wheninstalled onto a device enable the device to perform actions, including:display, on a display coupled to the computer processor, atwo-dimensional representation of an arrangement of electrodes of a leadhaving one or more segmented electrodes; display, on the display, athree-dimensional clinical effects map with two of the dimensions of theclinical effects map corresponding to the two-dimensional representationof the arrangement of the electrode and a third dimension correspondingto a stimulation parameter; and display, on the display, at least onemarking on the clinical effects map. Each marking represents astimulation instance and is displayed at a position corresponding to theelectrode used for stimulation in the stimulation instance and a valueof the stimulation parameter used for stimulation in the stimulationinstance. Each marking has a graphical characteristic representing atherapeutic effect or a side-effect resulting from the stimulationinstance.

In at least some embodiments, the actions further include receive aselection of a one of the at least one marking; and transmit electricalstimulation parameters corresponding to the one of the at least onemarking to an electrical stimulation system for delivery of electricalstimulation to a patient using the stimulation parameters.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic side view of one embodiment of a device for brainstimulation, according to the invention;

FIG. 2 is a schematic diagram of radial current steering along variouselectrode levels along the length of a lead, according to the invention;

FIG. 3A is a perspective view of an embodiment of a portion of a leadhaving a plurality of segmented electrodes, according to the invention;

FIG. 3B is a perspective view of a second embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 3C is a perspective view of a third embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 3D is a perspective view of a fourth embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 3E is a perspective view of a fifth embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 3F is a perspective view of a sixth embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 3G is a perspective view of a seventh embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 3H is a perspective view of an eighth embodiment of a portion of alead having a plurality of segmented electrodes, according to theinvention;

FIG. 4 is a schematic illustration of one embodiment of atwo-dimensional representation of the electrodes of the lead of FIG. 3G,according to the invention;

FIG. 5 is a schematic illustration of one embodiment of a clinicaleffects map using the two-dimensional representation of FIG. 4,according to the invention;

FIG. 6 is a schematic illustration of the clinical effects map of FIG. 5with one electrode and corresponding column of markings highlighted,according to the invention;

FIG. 7A is a schematic illustration of the clinical effects map of FIG.5 with one marking and the corresponding electrode highlighted,according to the invention;

FIG. 7B is a schematic illustration of the clinical effects map of FIG.5 with a shadow extending between a selected marking and thecorresponding electrode, according to the invention;

FIG. 8 is a schematic illustration of another embodiment of a clinicaleffects map using the two-dimensional representation of FIG. 4,according to the invention;

FIG. 9 is a schematic illustration of one embodiment of a user interfaceincorporating the clinical effects map of FIG. 5, according to theinvention; and

FIG. 10 is a schematic illustration of one embodiment of a system forpracticing the invention.

DETAILED DESCRIPTION

The invention is directed to the area of electrical stimulation systemsand leads and methods of making and using the systems and leads. Thepresent invention is also directed to electrical stimulation leads withsegmented electrodes formed from pre-electrodes with exteriordepressions or apertures, as well as methods of making and using thesegmented electrodes, leads, and electrical stimulation systems.

A lead for deep brain stimulation can include stimulation electrodes,recording electrodes, or a combination of both. At least some of thestimulation electrodes, recording electrodes, or both are provided inthe form of segmented electrodes that extend only partially around thecircumference of the lead. These segmented electrodes can be provided insets of electrodes, with each set having electrodes radially distributedabout the lead at a particular longitudinal position. For illustrativepurposes, the leads are described herein relative to use for deep brainstimulation, but it will be understood that any of the leads can be usedfor applications other than deep brain stimulation, including spinalcord stimulation, peripheral nerve stimulation, or stimulation of othernerves and tissues.

Suitable implantable electrical stimulation systems include, but are notlimited to, a least one lead with one or more electrodes disposed on adistal end of the lead and one or more terminals disposed on one or moreproximal ends of the lead. Leads include, for example, percutaneousleads. Examples of electrical stimulation systems with leads are foundin, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029;6,609,032; 6,741,892; 7,244,150; 7,450,997; 7,672,734;7,761,165;7,783,359; 7,792,590; 7,809,446; 7,949,395; 7,974,706; 8,175,710;8,224,450; 8,271,094; 8,295,944; 8,364,278; 8,391,985;and 8,688,235; andU.S. patent applications Publication Nos. 2007/0150036; 2009/0187222;2009/0276021; 2010/0076535; 2010/0268298; 2011/0005069; 2011/0004267;2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129; 2011/0313500;2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911; 2012/0197375;2012/0203316; 2012/0203320; 2012/0203321; 2012/0316615; 2013/0105071;and 2013/0197602, all of which are incorporated by reference.

In at least some embodiments, a practitioner may determine the positionof the target neurons using recording electrode(s) and then position thestimulation electrode(s) accordingly. In some embodiments, the sameelectrodes can be used for both recording and stimulation. In someembodiments, separate leads can be used; one with recording electrodeswhich identify target neurons, and a second lead with stimulationelectrodes that replaces the first after target neuron identification.In some embodiments, the same lead can include both recording electrodesand stimulation electrodes or electrodes can be used for both recordingand stimulation.

FIG. 1 illustrates one embodiment of a device 100 for electricalstimulation (for example, brain or spinal cord stimulation). The deviceincludes a lead 110, a plurality of electrodes 125 disposed at leastpartially about a circumference of the lead 110, a plurality ofterminals 135, a connector 132 for connection of the electrodes to acontrol module, and a stylet 140 for assisting in insertion andpositioning of the lead in the patient's brain. The stylet 140 can bemade of a rigid material. Examples of suitable materials for the styletinclude, but are not limited to, tungsten, stainless steel, and plastic.The stylet 140 may have a handle 150 to assist insertion into the lead110, as well as rotation of the stylet 140 and lead 110. The connector132 fits over a proximal end of the lead 110, preferably after removalof the stylet 140. The connector 132 can be part of a control module 133or can be part of an optional lead extension 131 that is coupled to thecontrol module.

The control module 133 can be an implantable pulse generator that can beimplanted into a patient's body, for example, below the patient'sclavicle area. The control module can have eight stimulation channelswhich may be independently programmable to control the magnitude of thecurrent stimulus from each channel. In some cases the control module canhave more or fewer than eight stimulation channels (e.g., 4-, 6-, 16-,32-, or more stimulation channels). The control module can have one,two, three, four, or more connector ports, for receiving the pluralityof terminals 135 at the proximal end of the lead 110. Examples ofcontrol modules are described in the references cited above.

In one example of operation, access to the desired position in the braincan be accomplished by drilling a hole in the patient's skull or craniumwith a cranial drill (commonly referred to as a burr), and coagulatingand incising the dura mater, or brain covering. The lead 110 can beinserted into the cranium and brain tissue with the assistance of thestylet 140. The lead 110 can be guided to the target location within thebrain using, for example, a stereotactic frame and a microdrive motorsystem. In some embodiments, the microdrive motor system can be fully orpartially automatic. The microdrive motor system may be configured toperform one or more the following actions (alone or in combination):insert the lead 110, retract the lead 110, or rotate the lead 110.

In some embodiments, measurement devices coupled to the muscles or othertissues stimulated by the target neurons, or a unit responsive to thepatient or clinician, can be coupled to the control module or microdrivemotor system. The measurement device, user, or clinician can indicate aresponse by the target muscles or other tissues to the stimulation orrecording electrode(s) to further identify the target neurons andfacilitate positioning of the stimulation electrode(s). For example, ifthe target neurons are directed to a muscle experiencing tremors, ameasurement device can be used to observe the muscle and indicatechanges in tremor frequency or amplitude in response to stimulation ofneurons. Alternatively, the patient or clinician can observe the muscleand provide feedback.

The lead 110 for deep brain stimulation can include stimulationelectrodes, recording electrodes, or both. In at least some embodiments,the lead 110 is rotatable so that the stimulation electrodes can bealigned with the target neurons after the neurons have been locatedusing the recording electrodes.

Stimulation electrodes may be disposed on the circumference of the lead110 to stimulate the target neurons. Stimulation electrodes may bering-shaped so that current projects from each electrode equally inevery direction from the position of the electrode along a length of thelead 110. Ring electrodes typically do not enable stimulus current to bedirected from only a limited angular range around of the lead. Segmentedelectrodes, however, can be used to direct stimulation energy to aselected angular range around the lead. When segmented electrodes areused in conjunction with an implantable control module that deliversconstant current stimulus, current steering can be achieved to moreprecisely deliver the stimulus to a position around an axis of the lead(i.e., radial positioning around the axis of the lead).

To achieve current steering, segmented electrodes can be utilized inaddition to, or as an alternative to, ring electrodes. Though thefollowing description discusses stimulation electrodes, it will beunderstood that all configurations of the stimulation electrodesdiscussed may be utilized in arranging recording electrodes as well. Alead that includes segmented electrodes can be referred to as adirectional lead because the segmented electrodes can be used to directstimulation along a particular direction or range of directions.

The lead 100 includes a lead body 110, one or more optional ringelectrodes 120, and a plurality of sets of segmented electrodes 130. Thelead body 110 can be formed of a biocompatible, non-conducting materialsuch as, for example, a polymeric material. Suitable polymeric materialsinclude, but are not limited to, silicone, polyurethane, polyurea,polyurethane-urea, polyethylene, or the like. Once implanted in thebody, the lead 100 may be in contact with body tissue for extendedperiods of time. In at least some embodiments, the lead 100 has across-sectional diameter of no more than 1.5 mm and may be in the rangeof 0.5 to 1.5 mm. In at least some embodiments, the lead 100 has alength of at least 10 cm and the length of the lead 100 may be in therange of 10 to 70 cm.

The electrodes can be made using a metal, alloy, conductive oxide, orany other suitable conductive biocompatible material. Examples ofsuitable materials include, but are not limited to, platinum, platinumiridium alloy, iridium, titanium, tungsten, palladium, palladiumrhodium, or the like. Preferably, the electrodes are made of a materialthat is biocompatible and does not substantially corrode under expectedoperating conditions in the operating environment for the expectedduration of use.

Each of the electrodes can either be used or unused (OFF). When theelectrode is used, the electrode can be used as an anode or cathode andcarry anodic or cathodic current. In some instances, an electrode mightbe an anode for a period of time and a cathode for a period of time.

Stimulation electrodes in the form of ring electrodes 120 can bedisposed on any part of the lead body 110, usually near a distal end ofthe lead 100. In FIG. 1, the lead 100 includes two ring electrodes 120.Any number of ring electrodes 120 can be disposed along the length ofthe lead body 110 including, for example, one, two three, four, five,six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen,fifteen, sixteen or more ring electrodes 120. It will be understood thatany number of ring electrodes can be disposed along the length of thelead body 110. In some embodiments, the ring electrodes 120 aresubstantially cylindrical and wrap around the entire circumference ofthe lead body 110. In some embodiments, the outer diameters of the ringelectrodes 120 are substantially equal to the outer diameter of the leadbody 110. The length of the ring electrodes 120 may vary according tothe desired treatment and the location of the target neurons. In someembodiments the length of the ring electrodes 120 are less than or equalto the diameters of the ring electrodes 120. In other embodiments, thelengths of the ring electrodes 120 are greater than the diameters of thering electrodes 120. The distal-most ring electrode 120 may be a tipelectrode (see, e.g., tip electrode 320 a of FIG. 3E) which covers most,or all, of the distal tip of the lead.

Deep brain stimulation leads may include one or more sets of segmentedelectrodes. Segmented electrodes may provide for superior currentsteering than ring electrodes because target structures in deep brainstimulation are not typically symmetric about the axis of the distalelectrode array. Instead, a target may be located on one side of a planerunning through the axis of the lead. Through the use of a radiallysegmented electrode array (“RSEA”), current steering can be performednot only along a length of the lead but also around a circumference ofthe lead. This provides precise three-dimensional targeting and deliveryof the current stimulus to neural target tissue, while potentiallyavoiding stimulation of other tissue. Examples of leads with segmentedelectrodes include U.S. patent applications Publication Nos.2010/0268298; 2011/0005069; 2011/0078900; 2011/0130803; 2011/0130816;2011/0130817; 2011/0130818; 2011/0078900; 2011/0238129; 2011/0313500;2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911; 2012/197375;2012/0203316; 2012/0203320; 2012/0203321; 2013/0197602; 2013/0261684;2013/0325091; 2013/0317587; 2014/0039587; 2014/0353001; 2014/0358209;2014/0358210; 2015/0018915; 2015/0021817; 2015/0045864; 2015/0021817;2015/0066120; 2013/0197424; 2015/0151113; 2014/0358207; and U.S. Pat.No. 8,483,237, all of which are incorporated herein by reference intheir entireties. Examples of leads with tip electrodes include at leastsome of the previously cited references, as well as U.S. patentapplications Publication Nos. 2014/0296953 and 2014/0343647, all ofwhich are incorporated herein by reference in their entireties.

The lead 100 is shown having a plurality of segmented electrodes 130.Any number of segmented electrodes 130 may be disposed on the lead body110 including, for example, one, two three, four, five, six, seven,eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteenor more segmented electrodes 130. It will be understood that any numberof segmented electrodes 130 may be disposed along the length of the leadbody 110. A segmented electrode 130 typically extends only 75%, 67%,60%, 50%, 40%, 33%, 25%, 20%, 17%, 15%, or less around the circumferenceof the lead.

The segmented electrodes 130 may be grouped into sets of segmentedelectrodes, where each set is disposed around a circumference of thelead 100 at a particular longitudinal portion of the lead 100. The lead100 may have any number segmented electrodes 130 in a given set ofsegmented electrodes. The lead 100 may have one, two, three, four, five,six, seven, eight, or more segmented electrodes 130 in a given set. Inat least some embodiments, each set of segmented electrodes 130 of thelead 100 contains the same number of segmented electrodes 130. Thesegmented electrodes 130 disposed on the lead 100 may include adifferent number of electrodes than at least one other set of segmentedelectrodes 130 disposed on the lead 100.

The segmented electrodes 130 may vary in size and shape. In someembodiments, the segmented electrodes 130 are all of the same size,shape, diameter, width or area or any combination thereof. In someembodiments, the segmented electrodes 130 of each circumferential set(or even all segmented electrodes disposed on the lead 100) may beidentical in size and shape.

Each set of segmented electrodes 130 may be disposed around thecircumference of the lead body 110 to form a substantially cylindricalshape around the lead body 110. The spacing between individualelectrodes of a given set of the segmented electrodes may be the same,or different from, the spacing between individual electrodes of anotherset of segmented electrodes on the lead 100. In at least someembodiments, equal spaces, gaps or cutouts are disposed between eachsegmented electrode 130 around the circumference of the lead body 110.In other embodiments, the spaces, gaps or cutouts between the segmentedelectrodes 130 may differ in size or shape. In other embodiments, thespaces, gaps, or cutouts between segmented electrodes 130 may be uniformfor a particular set of the segmented electrodes 130, or for all sets ofthe segmented electrodes 130. The sets of segmented electrodes 130 maybe positioned in irregular or regular intervals along a length the leadbody 110.

Conductor wires that attach to the ring electrodes 120 or segmentedelectrodes 130 extend along the lead body 110. These conductor wires mayextend through the material of the lead 100 or along one or more lumensdefined by the lead 100, or both. The conductor wires couple theelectrodes 120, 130 to the terminals 135.

When the lead 100 includes both ring electrodes 120 and segmentedelectrodes 130, the ring electrodes 120 and the segmented electrodes 130may be arranged in any suitable configuration. For example, when thelead 100 includes two ring electrodes 120 and two sets of segmentedelectrodes 130, the ring electrodes 120 can flank the two sets ofsegmented electrodes 130 (see e.g., FIGS. 1, 3A, and 3E-3H—ringelectrodes 320 and segmented electrode 330). Alternately, the two setsof ring electrodes 120 can be disposed proximal to the two sets ofsegmented electrodes 130 (see e.g., FIG. 3C—ring electrodes 320 andsegmented electrode 330), or the two sets of ring electrodes 120 can bedisposed distal to the two sets of segmented electrodes 130 (see e.g.,FIG. 3D—ring electrodes 320 and segmented electrode 330). One of thering electrodes can be a tip electrode (see, tip electrode 320 a ofFIGS. 3E and 3G). It will be understood that other configurations arepossible as well (e.g., alternating ring and segmented electrodes, orthe like).

By varying the location of the segmented electrodes 130, differentcoverage of the target neurons may be selected. For example, theelectrode arrangement of FIG. 3C may be useful if the physiciananticipates that the neural target will be closer to a distal tip of thelead body 110, while the electrode arrangement of FIG. 3D may be usefulif the physician anticipates that the neural target will be closer to aproximal end of the lead body 110.

Any combination of ring electrodes 120 and segmented electrodes 130 maybe disposed on the lead 100. For example, the lead may include a firstring electrode 120, two sets of segmented electrodes; each set formed offour segmented electrodes 130, and a final ring electrode 120 at the endof the lead. This configuration may simply be referred to as a 1-4-4-1configuration (FIGS. 3A and 3E—ring electrodes 320 and segmentedelectrode 330). It may be useful to refer to the electrodes with thisshorthand notation. Thus, the embodiment of FIG. 3C may be referred toas a 1-1-4-4 configuration, while the embodiment of FIG. 3D may bereferred to as a 4-4-1-1 configuration. The embodiments of FIGS. 3F, 3G,and 3H can be referred to as a 1-3-3-1 configuration. Other electrodeconfigurations include, for example, a 2-2-2-2 configuration, where foursets of segmented electrodes are disposed on the lead, and a 4-4configuration, where two sets of segmented electrodes, each having foursegmented electrodes 130 are disposed on the lead. The 1-3-3-1 electrodeconfiguration of FIGS. 3F, 3G, and 3H has two sets of segmentedelectrodes, each set containing three electrodes disposed around thecircumference of the lead, flanked by two ring electrodes (FIGS. 3F and3H) or a ring electrode and a tip electrode (FIG. 3G). In someembodiments, the lead includes 16 electrodes. Possible configurationsfor a 16-electrode lead include, but are not limited to 4-4-4-4; 8-8;3-3-3-3-3-1 (and all rearrangements of this configuration); and2-2-2-2-2-2-2-2.

FIG. 2 is a schematic diagram to illustrate radial current steeringalong various electrode levels along the length of the lead 200. Whileconventional lead configurations with ring electrodes are only able tosteer current along the length of the lead (the z-axis), the segmentedelectrode configuration is capable of steering current in the x-axis,y-axis as well as the z-axis. Thus, the centroid of stimulation may besteered in any direction in the three-dimensional space surrounding thelead 200. In some embodiments, the radial distance, r, and the angle θaround the circumference of the lead 200 may be dictated by thepercentage of anodic current (recognizing that stimulation predominantlyoccurs near the cathode, although strong anodes may cause stimulation aswell) introduced to each electrode. In at least some embodiments, theconfiguration of anodes and cathodes along the segmented electrodesallows the centroid of stimulation to be shifted to a variety ofdifferent locations along the lead 200.

As can be appreciated from FIG. 2, the centroid of stimulation can beshifted at each level along the length of the lead 200. The use ofmultiple sets of segmented electrodes at different levels along thelength of the lead allows for three-dimensional current steering. Insome embodiments, the sets of segmented electrodes are shiftedcollectively (i.e., the centroid of simulation is similar at each levelalong the length of the lead). In at least some other embodiments, eachset of segmented electrodes is controlled independently. Each set ofsegmented electrodes may contain two, three, four, five, six, seven,eight or more segmented electrodes. It will be understood that differentstimulation profiles may be produced by varying the number of segmentedelectrodes at each level. For example, when each set of segmentedelectrodes includes only two segmented electrodes, uniformly distributedgaps (inability to stimulate selectively) may be formed in thestimulation profile. In some embodiments, at least three segmentedelectrodes 230 in a set are utilized to allow for true 360° selectivity.

As previously indicated, the foregoing configurations may also be usedwhile utilizing recording electrodes. In some embodiments, measurementdevices coupled to the muscles or other tissues stimulated by the targetneurons or a unit responsive to the patient or clinician can be coupledto the control module or microdrive motor system. The measurementdevice, user, or clinician can indicate a response by the target musclesor other tissues to the stimulation or recording electrodes to furtheridentify the target neurons and facilitate positioning of thestimulation electrodes. For example, if the target neurons are directedto a muscle experiencing tremors, a measurement device can be used toobserve the muscle and indicate changes in tremor frequency or amplitudein response to stimulation of neurons. Alternatively, the patient orclinician may observe the muscle and provide feedback.

The reliability and durability of the lead will depend heavily on thedesign and method of manufacture. Fabrication techniques discussed belowprovide methods that can produce manufacturable and reliable leads.

Returning to FIG. 1, when the lead 100 includes a plurality of sets ofsegmented electrodes 130, it may be desirable to form the lead 100 suchthat corresponding electrodes of different sets of segmented electrodes130 are radially aligned with one another along the length of the lead100 (see e.g., the segmented electrodes 130 shown in FIG. 1). Radialalignment between corresponding electrodes of different sets ofsegmented electrodes 130 along the length of the lead 100 may reduceuncertainty as to the location or orientation between correspondingsegmented electrodes of different sets of segmented electrodes.Accordingly, it may be beneficial to form electrode arrays such thatcorresponding electrodes of different sets of segmented electrodes alongthe length of the lead 100 are radially aligned with one another and donot radially shift in relation to one another during manufacturing ofthe lead 100.

In other embodiments, individual electrodes in the two sets of segmentedelectrodes 130 are staggered (see, FIG. 3B) relative to one anotheralong the length of the lead body 110. In some cases, the staggeredpositioning of corresponding electrodes of different sets of segmentedelectrodes along the length of the lead 100 may be designed for aspecific application.

Segmented electrodes can be used to tailor the stimulation region sothat, instead of stimulating tissue around the circumference of the leadas would be achieved using a ring electrode, the stimulation region canbe directionally targeted. In some instances, it is desirable to targeta parallelepiped (or slab) region 250 that contains the electrodes ofthe lead 200, as illustrated in FIG. 2. One arrangement for directing astimulation field into a parallelepiped region uses segmented electrodesdisposed on opposite sides of a lead.

FIGS. 3A-3H illustrate leads 300 with segmented electrodes 330, optionalring electrodes 320 or tip electrodes 320 a, and a lead body 310. Thesets of segmented electrodes 330 each include either two (FIG. 3B),three (FIGS. 3E-3H), or four (FIGS. 3A, 3C, and 3D) or any other numberof segmented electrodes including, for example, three, five, six, ormore. The sets of segmented electrodes 330 can be aligned with eachother (FIGS. 3A-3G) or staggered (FIG. 3H)

Any other suitable arrangements of segmented electrodes can be used. Asan example, arrangements in which segmented electrodes are arrangedhelically with respect to each other. One embodiment includes a doublehelix.

A treating physician typically would like to tailor the stimulationparameters (such as which one or more of the stimulating electrodecontacts to use, the stimulation pulse amplitude (such as current orvoltage amplitude depending on the stimulator being used,) thestimulation pulse width, the stimulation frequency, or the like or anycombination thereof) for a particular patient to improve theeffectiveness of the therapy. Electrical stimulation systems can providean interface that facilitates parameter selections, Examples of suchsystems and interfaces can be found in, for example, U.S. patentapplications Ser. Nos. 12/454,330; 12/454,312; 12/454,340; 12/454,3431;and 12/454,314 and U.S. patent application Publication No. 2014/0277284,all of which are incorporated herein by reference in their entireties.

Electrical stimulation (such as deep brain or spinal cord stimulation)can include a programming procedure that is often performed in aninitial session and, in at least some instances, at later sessions. Theprocedure can involve, for example, testing different sets ofstimulation parameters (which can include variations in the electrodesthat are selected as well as different electrical parameters such asamplitude, duration, pulse frequency, and the like) and annotating whenthere is a beneficial therapeutic effect or an unwanted side effect. Inat least some embodiments, the clinician performs a monopolar reviewtesting each electrode individually and recording therapeutic/beneficialeffects and side effects for each electrode on the lead corresponding todifferent values of the stimulation amplitude or other stimulationparameters. The clinician may also perform bipolar or multipolar reviewsusing two or more electrodes.

U.S. patent application Publication No. 2014/0277284, incorporatedherein by reference in its entirety, illustrates a user interface of aprogrammer (for example, a clinician programmer, remote control, or anyother suitable programming or computing device) that presents a clinicaleffects map where indications from, for example, a monopolar or bipolarreview of the electrodes can be presented in graphical form for a leadhaving only ring electrodes. The effects are mapped on a two dimensionalgrid where one dimension represents the electrodes, which are arrangedalong the longitudinal axis of the lead, and the other dimensionrepresents the stimulation amplitude.

When a directional lead (for example, a lead with segmented electrodes)is used a two-dimensional mapping may not be adequate to displayclinical effects for each of the different electrodes. The directionallead allows for variation in stimulation in both the longitudinaldirection (like a lead with only ring electrodes) and thecircumferential direction.

In at least some embodiments, a clinical map for a directional lead is athree-dimensional map that utilizes two dimensions to identify theelectrodes on the lead and a third dimension for a stimulationparameter, such as amplitude. For example, a three-dimensional map withx, y, and z axes can utilize two of those axes (for example, the x and yaxes) to identify the electrodes of the lead and can correspond, forexample, to the circumferential and longitudinal directions on the lead.The third axis (for example, the z axis) can represent a stimulationparameter, such as amplitude.

FIG. 4 is a two-dimensional representation 400 of the electrodes of thedirectional lead of FIG. 3G. The y-axis 402 corresponds to thelongitudinal axis of the lead starting with the tip electrode 320 a atthe bottom to the ring electrode 320 at the top with the two sets ofsegmented electrodes 330 in the middle. The x-axis 404 corresponds tothe circumference of the lead beginning at one of the segmentedelectrodes 330 a and proceeding around the lead to the segmentedelectrode 330 b, 330 c. It will be understood that any of the otherleads described herein, as well as other lead arrangements, can bepresented in a similar two-dimensional arrangement. In at least someembodiments, the two-dimensional representation can be considered aflattened map of the portion of the directional lead in a manner similarto a two-dimension map of the world is a flattened representation of theworld.

In at least some embodiments, the lead may have an orientation marker toindicate a rotational orientation of the lead. Examples of such markersor other orientation indicators can be found at, for example, U.S. Pat.Nos. 8,560,085; 8,744,596; 8,831,742; and 8,923,982 and U.S. patentapplication Publication No. 2009/0204192 and U.S. Provisional patentapplication Ser. No. 62/209,001, all of which are incorporated herein byreference in their entireties. In at least some embodiments, thetwo-dimensional representation 400 of the electrodes may also includeone or more optional markers 325 to indicate the rotational orientationof the electrodes in the two-dimensional representation. The one or moremarkers 325 can be similar in shape or size to marker(s) on the lead ormay be different in shape or size still indicate the rotationalorientation of the lead.

FIG. 5 illustrates one embodiment of a three-dimensional clinicaleffects map 500. The illustrated embodiment includes the two-dimensionalrepresentation 400 of FIG. 4 of the electrodes (including electrodes320, 320 a, 330 a, 330 b, 330 c) of the directional lead of FIG. 3G andthe optional marker 325. The illustrated embodiment includes three axes502, 504, 506. The x-axis 502 corresponds to the longitudinal axis ofthe lead, the y-axis 504 corresponds to the circumferential direction ofthe lead, and the z-axis 506 represents a stimulation parameter, such asstimulation amplitude. It will be understood that the axes can bearranged differently. The two-dimensional representation 400 is providedwith the map 500 to indicate to the user which electrode of the leadcorresponds to the markings 510 on the map.

Clinical effects markings 510 can be placed on the map 500 based onentries by a user, such as a clinician or patient. Clinical effectsmarkings 510 may also be based on information from other sources, suchas a database. In at least some embodiments, the clinical effectsmarkings 510 can be spheres as shown in the illustrated embodiment, butany other marking can be used including, but not limited to, circles,ovals, ellipsoids, squares, rectangles, cubes, parallelepipeds,triangles, pyramids, or the like. The position of each clinical effectsmarking 510 is based on the electrode used for the correspondingstimulation and the value of the stimulation parameter, such asstimulation amplitude, represented by the z-axis 506 in the illustratedembodiment.

In at least some embodiments, the clinical effects markings 510corresponding to each individual electrode can form columns 512 disposedover that electrode in the two-dimensional representation 400. Forexamples, columns 512, 512 a, 512 b, 512 c, and 512 d corresponds tostimulation using electrodes 320, 330 a, 330 b, 330 c, and 320 a,respectively. As a further example, column 512 a includes clinicaleffects markings 510 a-510 d which correspond to stimulation usingelectrode 330 a at different values of the stimulation parameterrepresented by the z-axis 506.

In at least some embodiments, the clinical effects markings 510 can bedifferent depending on whether the associated clinical effect is abeneficial effect or a side effect. For example, the color or pattern onthe clinical effects marking 510 can be different for beneficial effectsand side effects. Such differences may also be used to distinguishdifferent beneficial effects or different side effects.

Alternatively or additionally, the markings 510 may include a ring 514 aand a surface 514 b. The ring 514 a may represent a side effect and thesurface 514 b may represent a beneficial effect (or vice versa). Thering 514 a and the surface 514 b are preferably graphically demarcatedfrom each other, for example, by use of different colors or hatching. Inat least some embodiments, for those markings 510 for which there isonly an associated side effect, the ring 514 a is displayed about anempty center region and, for those markers for which there is only abeneficial effect, the surface 514 b is displayed without any ringsurrounding the surface (or with only a minimal ring or a ring of adifferent color). In other embodiments, the markings 510 can be dividedinto two parts (such as two hemispheres); one of which representsbeneficial effects and the other represents side effects.

In at least some embodiments, a score, rating or other quantitative orqualitative designation may be assigned to the beneficial effect or sideeffect associated with the markings 510. The rating, score, or otherdesignation may be based on any suitable rating scale (for example, theUnified Parkinson's Disease Rating Scale (UPDRS)). The rating, score, orother designation can be made by the clinician, patient, or any othersuitable person and can be based on quantitative measurements,qualitative factors, or any combination thereof. In at least someembodiments, the rating, score, or other designation can be indicated inthe clinical effects map 500 by variation in the markings 510 such as avariation in color, shade, intensity, saturation, cross-hatching,texture, or any other graphical characteristic of the markings. In theillustrated embodiment of FIG. 5, markings 510 a, 510 b are darker thanmarkings 510 c, 510 d which can indicate a difference in the rating,score, or other designation. For example, markings 510 a, 510 b mayindicate a higher score for a beneficial effect than markings 510 c, 510d or markings 510 a, 510 b may indicate a stronger side effect thanmarkings 510 c, 510 d. It will be understood that dark markings couldinstead indicate a lower score or a weaker side effect. In someembodiments, a key (not shown) within or adjacent to the map 500 may beprovided to indicate the variations in the marking and the correspondingrating, score, or other designation.

In at least some embodiments, a user of the interface can select one ofthe electrodes (for example, electrode 330 a) in the clinical effectsmap 500 and that electrode and the corresponding markings 510 (forexample, markings 510 a-510 d) can be highlighted, as illustrated inFIG. 6. The highlighting can take the form of brightening, forming aperimeter of a different or brighter color (e.g., white or black),changes in cross-hatching or texture or any other graphicalcharacteristic, or any other mechanism for distinguishing thehighlighted electrode and markings from the other electrodes andmarkings. Additionally or alternatively, selecting the electrode cancreate a shadow that extends from the electrode through the markingsassociated with that electrode.

In at least some embodiments, a user of the programmer can select one ofthe markings (for example, marking 510 b) in the map 500 and theassociated electrode (for example, electrode 330 a) and the marking canbe highlighted, as illustrated in FIG. 7A. In other embodiments, onlythe marking 510 is highlighted. The highlighting can take the form ofbrightening, forming a perimeter of a different or brighter color (e.g.,white or black), changes in cross-hatching or texture or any othergraphical characteristic, or any other mechanism for distinguishing thehighlighted electrode and markings from the other electrodes andmarkings. In some embodiments, a newly added (or the last added) marking510 may be highlighted with or without the associated electrode.

In at least some embodiments, a user of the programmer can select one ofthe markings (for example, marking 510 b) in the map 500 and a shadow511 or other graphical representation can connect the selected markingand the associated electrode (for example, electrode 330 a), asillustrated in FIG. 7B. The shadow 511 may extend only to the selectedmarking or may extend beyond the selected marking (as illustrated inFIG. 7B). Optionally, other markings related to the electrode may alsobe connected using the shadow 511 or other graphical marking. In someembodiments, the selected marking or the electrode or both may also behighlighted. The highlighting can take the form of brightening, forminga perimeter of a different or brighter color (e.g., white or black),changes in cross-hatching or texture or any other graphicalcharacteristic, or any other mechanism for distinguishing thehighlighted electrode and markings from the other electrodes andmarkings.

In at least some embodiments, the two-dimensional representation of theelectrodes (or even just a representation of one or more of theelectrodes) may be moved up or down with respect to the markings 512.This can facilitate identifying which markings correspond to whichelectrodes.

In at least some embodiments, designators 522 can be associated witheach of the electrodes, as illustrated in FIG. 8. The designator 522 canbe a number (as illustrated in FIG. 8), letter, symbol, color,cross-hatching, texture, or the like. The presence of a designator 522may facilitate entry of data by providing a convenient mechanism forentry of the electrode to which the data is to be associated.

In at least some embodiments, additional markings can be extrapolatedfrom the existing markings and added to the map 500. The embodimentsdescribed above include individual markings. In at least someembodiments, a surface can be illustrated on the map to indicate, forexample, a surface with constant scores for one or more of the effectsor side-effects. The surface may be extrapolated from entries providedby a user. There may be multiple surfaces or a contoured surface withcontour lines indicating different scores. It will be understood that acomposite score or composite surface or contoured surface can also beillustrated using information regarding multiple effects/side-effects.

Any of the features described above can be combined in any suitablecombination. In addition, in at least some embodiments, the entirethree-dimensional plot can be rotated about the axis 506. In at leastsome embodiments, the entire three-dimensional plot can be rotated aboutthe other axes 502, 504 including allowing a top or bottom view of themap 500.

FIG. 9 illustrates one embodiment of a user interface 950 that caninclude a clinical effects map 500. It will be understood that aclinical effects map can be included in other user interfaces and thatthe one illustrated in FIG. 9 is just one example. The user interface950 include a variety of other controls, displays, and information andany user interface 950 can include any subset of these controls,displays, and information and may include other elements as well. In atleast some embodiments, the user interface 950 may also be useful forselecting stimulation parameters. The user interface 950 may include amodel 952 of a portion of the lead containing electrodes 954. In atleast some embodiments, the model 952 can be a three-dimensional modelof the portion of the lead, as illustrated in FIG. 9. The electrodes 954can include segmented electrodes 954 a, ring electrodes 954 b, or tipelectrodes 954 c or any combination thereof. The electrode 954 cancorrespond to the electrodes in the two-dimensional representation 400of the clinical effects map 500.

The model 952 optionally also includes a representation of the controlmodule 956. The model 952 may also display information such as thepolarity and amplitude for any of the electrodes being used for aparticular electrical stimulation selected by the user. The userinterface 950 can include one or more controls 958 for selecting theamplitude or polarity and one or more control 960 for selecting otherstimulation parameters, such as pulse width, pulse rate, and the like.In the illustrated user interface 950, the user selects the electrode954 and then controls 958 can be used to adjust the amplitude orpolarity for that electrode. The user interface can also includecontrols 962 for rotating the amplitude around the lead; controls 964for moving the amplitude longitudinally along the lead; or controls 966for widening or narrowing the distribution of the amplitude; or anycombination of these controls.

In at least some embodiments, if one of the electrodes 954 in the model952 is selected, then the corresponding electrode in the two-dimensionalrepresentation 400 and, optionally, markings 510 associated with thatelectrode are highlighted. In at least some embodiments, if one of theelectrodes 954 in the two-dimensional representation 400 is selected,then the corresponding electrode in the model 952 and, optionally,markings 510 associated with that electrode are highlighted. In at leastsome embodiments, if one of the markings 510 in the clinical effects map500 is selected, then the corresponding electrode in the model 952 andin the two-dimensional representation is highlighted.

The user interface 950 can also include controls 968 by which the usercan input information regarding beneficial effects. The controls 968 aprovide for entry of a rating or score and the control 968 b provide forentry of the type of effect. In some embodiments, the types of effectscan be user designated. In addition, there may be a control (labeled inFIG. 9 as “More . . . ”) for selection if none of the listed effects isapplicable. The user interface 950 can also include controls 970 bywhich the user can input information regarding side-effects. Thecontrols 970 a provide for entry of a rating or score and the control970 b provide for entry of the type of side-effect. In some embodiments,the types of side-effects can be user designated. In addition, there maybe a control (labeled in FIG. 9 as “More . . . ”) for selection if noneof the listed side-effects is applicable. The user interface can alsoinclude a control 972 for entry of notes. In some embodiments, if aparticular marking 510 is selected (or, in some embodiments, if thecursor hovers over or near the marking 510), then information regardingthat marking will be displayed such as, rating/score, type of effect orside-effect, or any notes or any combination thereof. In someembodiments, selection of the “More . . . ” control will produce a menuslisting additional therapeutic effects or side effects for whichcontrols are not displayed on the main screen.

In at least some embodiments, the user interface may also allow the userto filter out one or more effects or side-effects so that those effectsor side-effects are not illustrated in map 500 or to select one or moreeffects or side-effects so that only information regarding the selectedeffects or side-effects is illustrated in map 500. In at least someembodiments, the user interface may allow the user to filter based onscore, for example, filter out information where the score for an effector side-effect is below or above a specified threshold value. Thesefeatures may be combined together to allow filtering byeffect/side-effects and by score (including allowing filtering usingdifferent scores for different effects/side-effects) and used with anyof the maps described above.

Examples of user interfaces in which the clinical effects map 500 can beincorporated can be found at U.S. patent application Publication No.2014/0277284, incorporated herein by reference in its entirety, whichalso discusses additional controls and functions and further detailsregarding the controls and functions described above.

FIG. 10 illustrates one embodiment of a system for practicing theinvention. The system can include a computing device 1000 or any othersimilar device that includes a processor 1002 and a memory 1004, adisplay 1006, an input device 1008, and, optionally, the electricalstimulation system 1012.

The computing device 1000 can be a computer, tablet, mobile device, orany other suitable device for processing information and for presentinga user interface (such as user interface 900 of FIG. 9) or a clinicaleffects map (such as clinical effects map 500 of FIG. 5-8.) Thecomputing device can be, for example, a programmer for the electricalstimulation system 1012. The computing device 1000 can be local to theuser or can include components that are non-local to the computerincluding one or both of the processor 1002 or memory 1004 (or portionsthereof). For example, in some embodiments, the user may operate aterminal that is connected to a non-local computing device. In otherembodiments, the memory can be non-local to the user.

The computing device 1000 can utilize any suitable processor 1002including one or more hardware processors that may be local to the useror non-local to the user or other components of the computing device.The processor 1002 is configured to execute instructions provided to theprocessor, as described below.

Any suitable memory 1004 can be used for the computing device 1002. Thememory 1004 illustrates a type of computer-readable media, namelycomputer-readable storage media. Computer-readable storage media mayinclude, but is not limited to, nonvolatile, non-transitory, removable,and non-removable media implemented in any method or technology forstorage of information, such as computer readable instructions, datastructures, program modules, or other data. Examples ofcomputer-readable storage media include RAM, ROM, EEPROM, flash memory,or other memory technology, CD-ROM, digital versatile disks (“DVD”) orother optical storage, magnetic cassettes, magnetic tape, magnetic diskstorage or other magnetic storage devices, or any other medium which canbe used to store the desired information and which can be accessed by acomputing device.

Communication methods provide another type of computer readable media;namely communication media. Communication media typically embodiescomputer-readable instructions, data structures, program modules, orother data in a modulated data signal such as a carrier wave, datasignal, or other transport mechanism and include any informationdelivery media. The terms “modulated data signal,” and “carrier-wavesignal” includes a signal that has one or more of its characteristicsset or changed in such a manner as to encode information, instructions,data, and the like, in the signal. By way of example, communicationmedia includes wired media such as twisted pair, coaxial cable, fiberoptics, wave guides, and other wired media and wireless media such asacoustic, RF, infrared, and other wireless media.

The display 1006 can be any suitable display device, such as a monitor,screen, display, or the like, and can include a printer. The inputdevice 1008 can be, for example, a keyboard, mouse, touch screen, trackball, joystick, voice recognition system, or any combination thereof, orthe like and can be used by the user to interact with a user interfaceor clinical effects map.

The electrical stimulation system 1012 can include, for example, acontrol module 1014 (for example, an implantable pulse generator) and alead 1016 (for example, the lead illustrated in FIG. 1.) The electricalstimulation system 1012 may communicate with the computing device 1000through a wired or wireless connection or, alternatively oradditionally, a user can provide information between the electricalstimulation system 1012 and the computing device 1000 using acomputer-readable medium or by some other mechanism. In someembodiments, the computing device 1000 may include part of theelectrical stimulation system.

The methods and systems described herein may be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Accordingly, the methods and systemsdescribed herein may take the form of an entirely hardware embodiment,an entirely software embodiment or an embodiment combining software andhardware aspects. Systems referenced herein typically include memory andtypically include methods for communication with other devices includingmobile devices. Methods of communication can include both wired andwireless (e.g., RF, optical, or infrared) communications methods andsuch methods provide another type of computer readable media; namelycommunication media. Wired communication can include communication overa twisted pair, coaxial cable, fiber optics, wave guides, or the like,or any combination thereof. Wireless communication can include RF,infrared, acoustic, near field communication, Bluetooth™, or the like,or any combination thereof.

In addition to using the clinical effects map 500 to review previouslyrecorded clinical response information or to enter new clinical responsedata, the clinical effects map 500 can be used to select electricalstimulation parameters for an electrical stimulation system. Thecomputing device 1000 may present the clinical effects map 500 and userinterface 900 allowing the user to select stimulation parameters thatcan then be provide by the computing device to the control module 1014of the electrical stimulation system 1012. These stimulation parametersare used to provide electrical stimulation to the patient using the lead1016.

The above specification, examples, and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A computer-implemented method comprising:displaying, by a computer processor and on a display coupled to thecomputer processor, a two-dimensional representation of an arrangementof electrodes of a lead having one or more segmented electrodes;displaying, by the computer processor and on the display, athree-dimensional clinical effects map with two of the dimensions of theclinical effects map corresponding to the two-dimensional representationof the arrangement of the electrode and a third dimension correspondingto a stimulation parameter; and displaying, by the computer processorand on the display, at least one marking on the clinical effects map,wherein each marking represents a stimulation instance and is displayedat a position corresponding to the electrode used for stimulation in thestimulation instance and a value of the stimulation parameter used forstimulation in the stimulation instance, wherein each marking has agraphical characteristic representing a therapeutic effect or aside-effect resulting from the stimulation instance.
 2. The method ofclaim 1, further comprising selecting a one of the at least one marking;and delivering, by the processor, electrical stimulation parameterscorresponding to the one of the at least one marking to an electricalstimulation system for delivery of electrical stimulation to a patientusing the stimulation parameters.
 3. The method of claim 2, whereindelivering electrical stimulation parameters comprises delivering, tothe electrical stimulation system, an identification of the electrodeassociated with the one of the at least one marking and the value of thestimulation parameter associated with the one of the at least onemarking.
 4. The method of claim 1, wherein the stimulation parameter towhich the third dimension corresponds is stimulation amplitude.
 5. Themethod of claim 1, wherein the graphical characteristic is selected fromcolor or cross-hatching.
 6. The method of claim 1, wherein displaying atleast one marking comprises displaying the at least one marking with afurther graphical characteristic representing a score or rating of thetherapeutic effect or the side-effect resulting from the stimulationinstance.
 7. The method of claim 6, wherein the further graphicalcharacteristic is selected from color, shade, intensity, saturation,cross-hatching, or texture.
 8. The method of claim 1, wherein displayingat least one marking comprises displaying at least one of the at leastone marking with a first graphical characteristic representing a firsttherapeutic effect resulting from the stimulation instance and a secondgraphical characteristic representing a first side-effect resulting fromthe stimulation instance.
 9. The method of claim 8, wherein the firstgraphical characteristic is associated with a surface of the marking andthe second graphical characteristic is associated with a perimeter ringof the marking.
 10. The method of claim 1, wherein displaying at leastone marking comprises displaying a plurality of markings associated withone of the electrodes of the lead in a column.
 11. The method of claim1, further comprising selecting a one of the electrodes in thetwo-dimensional representation and highlighting all of the at least onemarkings associated with the selected electrode.
 12. The method of claim1, further comprising displaying, by the computer processor and on thedisplay, a three-dimensional representation of the arrangement of theelectrodes of the lead separate from, and simultaneously with, theclinical effects map and two-dimensional representation.
 13. The methodof claim 12, further comprising selecting a one of the electrodes in thethree-dimensional representation and highlighting all of the at leastone markings associated with the selected electrode and highlighting theselected electrode in the two-dimensional representation.
 14. The methodof claim 12, further comprising selecting a one of the electrodes in thetwo-dimensional representation and highlighting all of the at least onemarkings associated with the selected electrode and highlighting theselected electrode in the three-dimensional representation.
 15. Themethod of claim 1, further comprising selecting a one of the at leastone marking and highlighting the one of the at least one marking and theelectrode, in the two-dimensional representation, associated with theselected one of the at least one marking.
 16. A system for mappingclinical effects of electrical stimulation, the system comprising: adisplay; and a computer processor coupled to the display and configuredand arranged to perform the following actions: display, on the display,a two-dimensional representation of an arrangement of electrodes of alead having one or more segmented electrodes; display, on the display, athree-dimensional clinical effects map with two of the dimensions of theclinical effects map corresponding to the two-dimensional representationof the arrangement of the electrode and a third dimension correspondingto a stimulation parameter; and display, on the display, at least onemarking on the clinical effects map, wherein each marking represents astimulation instance and is displayed at a position corresponding to theelectrode used for stimulation in the stimulation instance and a valueof the stimulation parameter used for stimulation in the stimulationinstance, wherein each marking has a graphical characteristicrepresenting a therapeutic effect or a side-effect resulting from thestimulation instance.
 17. The system of claim 16, wherein the actionsfurther comprise receive a selection of a one of the at least onemarking; and transmit electrical stimulation parameters corresponding tothe one of the at least one marking to an electrical stimulation systemfor delivery of electrical stimulation to a patient using thestimulation parameters.
 18. The system of claim 16, wherein the actionsfurther comprise display, on the display, a three-dimensionalrepresentation of the arrangement of the electrodes of the lead separatefrom, and simultaneously with, the clinical effects map andtwo-dimensional representation.
 19. A non-transitory computer-readablemedium having processor-executable instructions for mapping clinicaleffects of electrical stimulation, the processor-executable instructionswhen installed onto a device enable the device to perform actions,including: display, on a display coupled to the computer processor, atwo-dimensional representation of an arrangement of electrodes of a leadhaving one or more segmented electrodes; display, on the display, athree-dimensional clinical effects map with two of the dimensions of theclinical effects map corresponding to the two-dimensional representationof the arrangement of the electrode and a third dimension correspondingto a stimulation parameter; and display, on the display, at least onemarking on the clinical effects map, wherein each marking represents astimulation instance and is displayed at a position corresponding to theelectrode used for stimulation in the stimulation instance and a valueof the stimulation parameter used for stimulation in the stimulationinstance, wherein each marking has a graphical characteristicrepresenting a therapeutic effect or a side-effect resulting from thestimulation instance.
 20. The non-transitory computer-readable medium ofclaim 19, wherein the actions further comprise receive a selection of aone of the at least one marking; and transmit electrical stimulationparameters corresponding to the one of the at least one marking to anelectrical stimulation system for delivery of electrical stimulation toa patient using the stimulation parameters.